LIVDELZI is for patients diagnosed with PBC who are having an inadequate or incomplete biochemical response to ursodeoxycholic acid (UDCA), or patients who are unable to tolerate UDCA.¹

This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).¹

LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (eg, ascites, variceal bleeding, hepatic encephalopathy).¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Review the efficacy data of LIVDELZI.

LIVDELZI is the first and only PBC treatment that achieved statistically significant reductions across key biomarkers and pruritus vs placebo.¹

In the RESPONSE trial, LIVDELZI helped to lower key PBC biomarkers, with 62% of patients achieving composite biochemical response at 12 months vs 20% of patients in the placebo arm (P<0.0001).^1,a

LIVDELZI also lowered ALP, with 25% of patients achieving ALP normalization at 12 months vs 0% of patients in the placebo arm (P<0.0001).¹

In addition, LIVDELZI was shown to lower pruritus, with a statistically significant difference at 6 months vs placebo (NRS -3.2 vs -1.7; P=0.0051).¹

A single-item, patient-reported outcome, the pruritus NRS, evaluated patients’ daily worst itching intensity on an 11-point rating scale, with scores ranging from 0 (“no itching”) to 10 (“worst itching imaginable”) in RESPONSE. The pruritus NRS was administered daily in a 14-day run-in period prior to randomization through 6 months and then for 7 consecutive days during each month up to the end of the treatment period.^1,2

The most common adverse reactions in the LIVDELZI and placebo arms, respectively, were headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).¹

Study design: RESPONSE was a 12-month, randomized, double-blind, pivotal trial that assessed the efficacy and safety of LIVDELZI 10 mg ± UDCA (n=128) vs placebo ± UDCA (n=65), administered once daily. The primary endpoint was composite biochemical response. Key secondary endpoints were ALP normalization at 12 months and change in pruritus NRS at 6 months in patients with baseline average pruritus score ≥4. Baseline average pruritus scores in the pruritus subgroup were 6.1 (LIVDELZI; n=49) and 6.6 (placebo; n=23).¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Learn more about disease and pruritus efficacy of LIVDELZI.

^aBiochemical response was defined as achieving the following at 12 months: ALP <1.67 x ULN, ≥15% decrease in ALP from baseline, and TB ≤1 x ULN.¹

In the RESPONSE trial, 25% of patients in the LIVDELZI arm achieved ALP normalization at 12 months vs 0% of patients in the placebo arm (P<0.0001).¹

LIVDELZI is the only PBC treatment to achieve this rate of ALP normalization.^1,3

The most common adverse reactions in the LIVDELZI and placebo arms, respectively, were headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).¹

Study design: RESPONSE was a 12-month, randomized, double-blind, pivotal trial that assessed the efficacy and safety of LIVDELZI 10 mg ± UDCA (n=128) vs placebo ± UDCA (n=65), administered once daily. The primary endpoint was composite biochemical response. Key secondary endpoints were ALP normalization at 12 months and change in pruritus NRS at 6 months in patients with baseline average pruritus score ≥4. Baseline average pruritus scores in the pruritus subgroup were 6.1 (LIVDELZI; n=49) and 6.6 (placebo; n=23).¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Review detailed LIVDELZI ALP efficacy data.

For patients with baseline average pruritus NRS score ≥4, LIVDELZI is the only PBC treatment with statistically significant pruritus improvement at 6 months vs placebo in the FDA-approved label (pruritus NRS -3.2 vs -1.7; P=0.0051).¹

The most common adverse reactions in the LIVDELZI and placebo arms, respectively, were headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).¹

Study design: RESPONSE was a 12-month, randomized, double-blind, pivotal trial that assessed the efficacy and safety of LIVDELZI 10 mg ± UDCA (n=128) vs placebo ± UDCA (n=65), administered once daily. The primary endpoint was composite biochemical response. Key secondary endpoints were ALP normalization at 12 months and change in pruritus NRS at 6 months in patients with baseline average pruritus score ≥4. Baseline average pruritus scores in the pruritus subgroup were 6.1 (LIVDELZI; n=49) and 6.6 (placebo; n=23).¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Review detailed LIVDELZI pruritus efficacy data.

In the RESPONSE trial, patient-reported outcomes, including fatigue, were evaluated in prespecified (overall intent-to-treat population) and post-hoc (subgroup) exploratory analyses using the PBC-40 scale.⁴

For patients on LIVDELZI, PBC-40 fatigue domain scores were observed in the overall intent-to-treat patient population as well as the subgroups of patients with NRS ≥4 and ≥7 at baseline.^2,4,5

These analyses were descriptive only and multiplicity was not controlled. Analyses are not presented in the full Prescribing Information for LIVDELZI. The post hoc subgroup analysis was not designed with statistical control and statistical comparisons were not performed. These data were not type 1 error controlled.

PBC-40 is a validated health-related questionnaire designed to quantify the impact of PBC across 6 domains: fatigue, social, other symptoms, cognitive, emotion, and itch. Each domain is scaled from 1 to 5 (higher scores represent greater impact).^1,2

The most common adverse reactions in the LIVDELZI and placebo arms, respectively, were headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).¹

RESPONSE was a 12-month, randomized, double-blind, pivotal trial that assessed the efficacy and safety of LIVDELZI 10 mg ± UDCA (n=128) vs placebo ± UDCA (n=65), administered once daily.¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Review detailed LIVDELZI fatigue and pruritus data.

In the RESPONSE trial, the most common adverse reactions in the LIVDELZI and placebo arms, respectively, were headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).¹

Patients treated with LIVDELZI experienced low rates of discontinuation due to adverse reactions (3.1%) vs patients in the placebo arm (4.6%).²

RESPONSE was a 12-month, randomized, double-blind, pivotal trial that assessed the efficacy and safety of LIVDELZI 10 mg ± UDCA (n=128) vs placebo ± UDCA (n=65), administered once daily.¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Learn more about the safety and tolerability profile of LIVDELZI.

LIVDELZI is a once-daily, 10 mg oral capsule that requires no dosage adjustments.¹

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Learn more about LIVDELZI dosing.

Your patients with PBC may be able to continue taking certain other medications with LIVDELZI. No clinically significant differences in the pharmacokinetics of the following drugs were observed in studies with LIVDELZI: tolbutamide, midazolam, and certain statins such as simvastatin, atorvastatin, or rosuvastatin.¹ Based on the metabolism of LIVDELZI, there are no expected interactions with estradiol, omeprazole, or ibuprofen.^1,6,7,a

^aCoadministration of LIVDELZI with estradiol or ibuprofen has not been formally studied.¹

Drug Interactions

Potential Increased Exposure of LIVDELZI with:

• Probenecid: Avoid coadministration with LIVDELZI.
• Strong CYP2C9 Inhibitors: Monitor for adverse effects during concomitant use.
• Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors (eg, fluconazole): Monitor for adverse effects during concomitant use.
• CYP2C9 Poor Metabolizers Using Moderate or Strong CYP3A4 Inhibitors: Monitor for adverse effects during concomitant use of a moderate or strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers.
• Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP (eg, cyclosporine): Monitor for adverse effects during concomitant use.

Potential Reduction in LIVDELZI Exposure with:

• Rifampin: Concomitant use of LIVDELZI with rifampin, an inducer of metabolizing enzymes, may result in delayed or suboptimal LIVDELZI biochemical response. Monitor biochemical response (eg, ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment.
• Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.

See below for Important Safety Information including warnings for fractures, liver test abnormalities, and biliary obstruction.

Learn more about the safety and tolerability profile of LIVDELZI.

The LIVDELZI Co-pay Savings Program may help your eligible patients with PBC save on out-of-pocket costs.^a

• Patients can save up to $10,000 annually
• No monthly limit
• Enroll by phone (1-855-769-7284) or online (MySupportPath.com)

99% of eligible patients pay $0-$10 per month for LIVDELZI.^8,b

Learn more about LIVDELZI financial and patient support programs.

^aCo-pay savings support is available for commercially insured eligible patients only. Additional restrictions apply. Subject to change; for full terms and conditions, visit www.mysupportpath.com/co-pay. This is not health insurance. Only accepted at participating pharmacies.

^bData from 09/2024 through 11/2025.

99% of patients with PBC who are eligible pay $0-$10 per month for LIVDELZI.^8,a,b

The LIVDELZI Co-pay Savings Program may help your eligible patients save on out-of-pocket costs.^b

• Patients can save up to $10,000 annually
• No monthly limit
• Enroll by phone (1-855-769-7284) or online (MySupportPath.com)

Learn more about LIVDELZI financial and patient support programs.

^aCo-pay savings support is available for commercially insured eligible patients only. Additional restrictions apply. Subject to change; for full terms and conditions, visit www.mysupportpath.com/co-pay. This is not health insurance. Only accepted at participating pharmacies.

^bData from 09/2024 through 11/2025.

LIVDELZI access is straightforward with 4 simple steps:

1. Send the prescription to the selected specialty pharmacy within the LIVDELZI limited distribution network
2. The specialty pharmacy will explain insurance coverage, submit prior authorization, and confirm medicine cost and financial assistance options^a
3. The specialty pharmacy will call the patient to schedule the delivery of the medicine
4. When it’s time for a refill, the specialty pharmacy will call the patient

Since launch, ~95% of patients prescribed LIVDELZI have received insurance approval upon first submission, streamlining access and minimizing delays in treatment initiation.^8,a,b

Learn more about how to order LIVDELZI.

^aIf additional support is required for your office staff or patient, you can request a Field Reimbursement Manager (FRM) or connect with Support Path^®.

^bData from 09/2024 through 01/2026.

LIVDELZI is available through a limited network of specialty pharmacies including AcariaHealth, Orsini, and PANTHERx Rare. CuraScript SD is the specialty distributor for LIVDELZI.

Learn more about how to order LIVDELZI.

The list of authorized distributors is updated periodically and is subject to change. Please visit gilead.com/purpose/medication-access/authorized-distributors for updates.

PBC is a chronic, progressive liver disease that damages a patient’s liver and impacts their day-to-day life due to significant symptoms.^3,9

With inadequate treatment, PBC may progress to end-stage liver disease and patients may experience associated complications including, but not limited to^9,10:

• Cholestasis
• Irreversible bile duct destruction
• Fibrosis
• Cirrhosis

Explore this deeper PBC overview to learn how your patients may be impacted by their disease.

In PBC, ALP is an important serum biomarker that is associated with disease progression and is commonly used to help assess prognosis.¹¹

Consistently elevated ALP may increase the risk of disease progression and poor outcomes for patients with PBC, including^9,12:

• Cholestasis
• Irreversible bile duct destruction
• Reduced transplant-free survival

Achieving normal ALP (≤1.0 x upper limit of normal) is recommended as a PBC management goal, as studies have shown normal ALP levels are associated with improved outcomes and longer transplant-free survival.^12-14,a

Review efficacy data around ALP normalization.

^aPatients (N=3059) from the GLOBAL PBC Study Group database were analyzed to determine whether bilirubin or ALP levels within the normal range (≤1.0 x ULN) were associated with survival in patients with PBC. The dataset included both untreated patients and patients treated with UDCA. The primary endpoint was a composite of liver transplant and all-cause mortality.¹³

The most common symptoms of PBC are pruritus and fatigue. Up to 70% of patients experience pruritus and up to 78% experience fatigue.³

Treatment with ursodeoxycholic acid (UDCA) may not achieve symptom relief.³

Discover more about PBC.

Review pivotal trial data for pruritus.

For patients with PBC, pruritus—particularly at night—has been associated with a higher likelihood of sleep disruption compared with patients who do not experience pruritus. Lack of restful sleep may contribute to increased fatigue in patients with PBC.^15,a

Explore this deeper PBC overview to learn how your patients may be impacted by their disease.

^aThe prevalence of prespecified comorbidities and medications in a PBC population (n=1963), a PBC-pruritus subpopulation (n=139), and a noncase population (n=10,245,592) was assessed over a 12-month period in a retrospective, cross-sectional study using data from the IBM MarketScan Commercial Claims and Medicare Supplemental Database.¹⁵

The standard management approach for all patients with PBC is first-line treatment with ursodeoxycholic acid (UDCA) at 13-15 mg/kg/day as recommended by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL).^2,7

Learn more about guidelines and considerations for PBC management.

See the most up-to-date treatment guidance from AASLD.

For patients with PBC, consideration of second-line treatment in addition to ursodeoxycholic acid (UDCA), or as monotherapy if unable to tolerate UDCA, is recommended in patients with inadequate biochemical response at 1 year by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL). Inadequate biochemical response at 1 year signifies a higher risk of PBC disease progression.^3,9

Recent research supports that biochemical response to UDCA may be reliably predicted at 6 months, allowing for earlier consideration of second-line therapy.^11,16-18,a

Explore additional guidelines and considerations for second-line PBC treatment.

See the most up-to-date treatment guidance from AASLD.

See the efficacy of LIVDELZI.

^aAn updated expert consensus (2023) recommends a 6-month threshold of ALP <1.9 x ULN + bilirubin <1.0 x ULN in patients with advanced fibrosis (VCTE or TE ≥10 kPa), compensated liver disease, and no portal hypertension, and to continue monitoring ALP and bilirubin every 3 to 6 months with an adequate response to UDCA.¹⁷

As PBC can continue to progress while patients are on ursodeoxycholic acid (UDCA), individual risk stratification and follow-up assessment for the need of additional treatment with second-line therapy should be evaluated.^9,19

Learn more about key patient characteristics to consider when managing patients with PBC.